Essentials of European Medical Device Regulatory Affairs

MDR Article 7 - Claims

In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user or the patient with regard to the device's intended purpose, safety and performance by: (a)ascribing functions and properties to the device which the device does not have; (b)creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have; (c)failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose; (d)suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

The Organisationfor Professionals inRegulatory Affairs

Advertising & Promotional Claims of Medical Devices

• Common assumption that advertising for medical devices is not regulated • The promotion of medical devices is governed by several EU Directives, most of which are of general application, as well as the EU member states national laws implementing such Directives • Ultimately, the real challenge resides in the identification of the applicable provisions and their implementation to the specific cases

The Organisationfor Professionals inRegulatory Affairs